A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 3/13/2019 |
Start Date: | November 18, 2016 |
End Date: | December 28, 2020 |
Contact: | ABBVIE CALL CENTER |
Email: | abbvieclinicaltrials@abbvie.com |
Phone: | 847.283.8955 |
A Multi-Center, Phase 1, Open-Label, Dose-Escalation Study of ABBV-428, an Immunotherapy in Subjects With Advanced Solid Tumors
This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2
dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK)
profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in
participants with advanced solid tumors.
dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK)
profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in
participants with advanced solid tumors.
Inclusion Criteria:
- Participants must have an advanced solid tumor that has progressed on standard
therapies known to provide clinical benefit or the participants are intolerant to such
therapies.
- Participants have adequate bone marrow, renal, hepatic and coagulation function.
- For all dose expansion arms, participants must have measurable disease per Response
Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Participants in combination therapy cohorts must have an advanced solid tumor where
the use of nivolumab is standard therapy.
Exclusion Criteria:
- Active or prior documented autoimmune disease in the last 2 years. Participants with
childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or
psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- Current or prior use of immunosuppressive medication within 14 days prior to the first
dose (with certain exceptions).
- History of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic
leukemia, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
- Confirmed positive test results for human immunodeficiency virus (HIV), or
participants with chronic or active hepatitis B or C. Participants who have a history
of hepatitis B or C who have undetectable HBV DNA or HCV RNA after anti-viral therapy
may be enrolled.
- Prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis
(or any other unresolved or symptomatic adverse event in the last 3 months) while
receiving immunotherapy.
- Male participants who are considering fathering a child or donating sperm during the
study or for at least 3 or 5 months (for monotherapy and combination therapy
participants, respectively) after the last dose of study drug.
We found this trial at
8
sites
4383 Medical Drive
San Antonio, Texas 78229
San Antonio, Texas 78229
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